Automatic Chlorination and Child Health in Urban Bangladesh

Diarrhea Clinical Trial

Official title:

Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality and Child Health in Urban Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606981
• Other study ID #: 30456
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: May 10, 2017
• Start date: July 2015
• Est. completion date: December 20, 2016

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Municipal water networks within industrialized countries typically rely on centralized treatment to manage piped water quality. Optimal water quality at the tap, however, requires well-maintained piped distribution networks, and performs best when piped systems are fully pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately maintained and typically supply intermittent service; as such, they are vulnerable to recontamination during negative pressure events. Among populations accessing these types of improved water sources in urban settings (e.g. shared taps), it is unknown if consistent treatment to provide chlorinated water at the point of collection would have a significant health benefit. Furthermore, almost all previous studies of water treatment interventions in low-income countries have been unblinded with self-reported diarrhea as the main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to social desirability bias. Stanford University in collaboration with icddr,b will conduct a randomized evaluation to assess the impact on access to automatically chlorinated water on water quality and child health.

Description:

Investigators will conduct a blinded cluster randomized controlled trial to evaluate the health and economic impacts of having access to automatically chlorinated water. The unit of randomization will be shared water points that typically serve 20-200 households. Shared water points connected to holding tanks compatible with the water treatment technology, and serving more than 4 households with at least one child under five, will be identified. Households accessing eligible water points as their primary drinking water source will be enrolled before installation of chlorine devices, and a baseline survey will be conducted of water quality, diarrhea prevalence, and health care expenditures. Following this baseline, households will be randomly assigned to control or treatment groups. The chlorination devices will be installed at the treatment group water points, while a doser containing vitamin C (and no chlorine), will be installed in the control group. The free chlorine dosing target will be below <1ppm to preserve blinding. All households will be surveyed every 2-3 months for a total follow up period of 14-16 months (5-7 survey rounds, budget permitting).

Objectives:

1. To evaluate the impact of an automated chlorination system on microbial stored drinking water quality, residual chlorine, user satisfaction, user perceptions of water taste and smell, under-five child diarrhea (longitudinal prevalence) compared to a control group.

2. Compare the marginal additional cost (per person served) of installing and maintaining an automated chlorination system integrated with the current water supply infrastructure in low-income areas of Dhaka.

3. Assess the impact of an automated chlorination system on hospital visits and health care expenditures.

4. To measure secondary outcomes of the impact of an automated chlorination system including under-five child weight-for-age (WAZ), under-five height-for-age (HAZ), as well as levels of C-reactive protein and immunoglobin G in serum samples collected from children under five (these are objective indicators of infection, such as repeat diarrheal episodes).

Analysis:

The primary analyses will be intent-to-treat (investigators will analyze differences in outcomes between the treatment and control groups, with groups defined by their random allocation). Investigators will also conduct a secondary analysis comparing outcomes between intervention and control, where the intervention group is defined as those households that had free chlorine residual detected in their stored drinking water (treated on the treated analysis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1549
• Est. completion date: December 20, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Months

Eligibility

Inclusion Criteria:

• Households with at least one child under 60 months old

• Households using enrolled shared water point as primary drinking water source

Exclusion Criteria:

• Households with a private drinking water source

Note: New births and children under 60 months that migrate into compounds accessing the enrolled water points for drinking water will be enrolled into the study.

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrhea
• Infection

Intervention

Device:
• Water chlorination by the Flogenic
The chlorine doser delivers a constant amount of chlorine into water as it flows into a holding tank. The water is then piped to public and private taps.
• Active control, vitamin C dosing into water
The control group will receive a vitamin C dosing device that looks identical to the intervention chlorine doser installed in the holding tank that feeds their shared water access point.

Locations

Country	Name	City	State
Bangladesh	Tongi and Dhaka Uddan	Tongi/Dhaka	Gazipur

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbial water quality	Colony forming units of the fecal indicator bacteria, E. coli	Measured monthly among a subset of households, for 16 months post baseline
Other	Chlorine residual in household stored drinking water	Free chlorine residual in ppm	Measured every 2-3 months for 16 months post baseline
Other	health related treatment and associated cost		Measured every 2-3 months for 16 months post baseline
Primary	Diarrhea longitudinal prevalence	1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours	Measured every 2-3 months for 16 months post baseline
Secondary	Weight-for-age-z-score	Weight-for-age z-score among children under five years	Measured every 2-3 months for 16 months post baseline
Secondary	Height-for-age-z-score	Height-for-age z-score among children under five	Measured at baseline and 16 months after baseline
Secondary	Respiratory illness longitudinal prevalence	one week recall period, symptoms include congestion, cough, difficulty breathing	Measured every 2-3 months for 16 months post baseline
Secondary	C-reactive protein		Measured at baseline and conclusion of study (16 months post baseline) among children under five
Secondary	total immunoglobin G (IgG)		Measured at baseline and conclusion of study (16 months post baseline) among children under five
Secondary	Prevalence and number of enteric pathogens		Measured 6-12 months after intervention delivery among children under five
Secondary	Caregiver defined diarrhea	1-week recall period, defined with local Bengali word for diarrhea	Measured every 2-3 months for 16 months post baseline